IEVL - Optical radiation safety and laser equipment

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a CLASS 3B or CLASS 4 LASER PRODUCT as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as LASER EQUIPMENT. Throughout this International Standard, light emitting diodes(LED) are included whenever the word “laser” is used.
NOTE 1 Refer to Definition 3.49 in IEC 60825-1.
NOTE 2 Laser products for these applications classified as a CLASS 1, 1M, 2, 2M or CLASS 3R LASER PRODUCT, are covered by IEC 60825-1 and IEC 60601-1. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARD inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specifi requirements in this standard except in 7.2.13 and 8.4.1 of the General Standard. NOTE See also 4.2 of the General Standard. This standard can also be applied to surgical, cosmetic, therapeutic and diagnostic laser equipment used for compensation or alleviation of disease, injury o disability.

This part of IEC 60825 specifies the requirements for laser guards, permanent and temporary (for example for service), that enclose the process zone of a laser processing machine, and specifications for proprietary laser guards. This standard applies to all component parts of a guard including clear (visibly transmitting) screens and viewing windows, panels, laser curtains and walls. Requirements for beam path components, beam stops and those other parts of a protective housing of a laser product which do not enclose the process zone are contained in IEC 60825-1. In addition this part of IEC 60825 indicates: a) how to assess and specify the protective properties of a laser guard; and b) how to select a laser guard.

This International Standard gives guidance for evaluating the photobiological safety of lamps and lamp systems including luminaires. Specifically it specifies the exposure limits, reference measurement technique and classification scheme for the evaluation and control of photobiological hazards from all electrically powered incoherent broadband sources of optical radiation, including LEDs but excluding lasers, in the wavelength range from 200 nm through 3000 nm.

This part of IEC 60825 specifies the requirements for laser guards, permanent and temporary (for example for service), that enclose the process zone of a laser processing machine, and specifications for proprietary laser guards. This standard applies to all component parts of a guard including clear (visibly transmitting) screens and viewing windows, panels, laser curtains and walls. Requirements for beam path components, beam stops and those other parts of a protective housing of a laser product which do not enclose the process zone are contained in IEC 60825-1. In addition this part of IEC 60825 indicates: a) how to assess and specify the protective properties of a laser guard; and b) how to select a laser guard.

This Technical Report, which contains the national wordings of  laser warning labels, is to be read inconjunction with EN  60825-1:1994.

Provides requirements and specific guidance for the safe operation and maintenance of optical fibre communication systems (OFCS). In these systems optical power may be accessible outside the confinements of transmitting equipment or at great distance from the optical source. This standard requires the assessment of hazard levels at accessible locations as a replacement for classification according to IEC 60825-1. It applies to the complete installed end-to-end OFCS, including its components and subassemblies that generate or amplify optical radiation. Individual components and subassemblies that are sold only to OEM vendors for incorporation into a complete installed end-to-end OFCS need not be assessed to this standard, since the final OFCS should itself be assessed according to this standard. The objective of this Part 2 of IEC 60825 is: to protect people from optical radiation resulting from OFCS; - provide requirements for manufacturers, installation organizations, service organizations and operating organizations in order to establish procedures and supply information so that proper precautions can be adopted; - ensure adequate warnings are provided to individuals regarding the potential hazards associated with OFCS through the use of signs, labels and instructions.

This Guide has been prepared in order to provide information and guidance to employers and employees in organisations in which lasers are used. It is supplementary to the safety requirements specified in the EN 60825 series of standards on laser safety. The Guide outlines procedures for the management of laser hazards and defines levels of competence for those who work with laser equipment or who have responsibility for laser safety.

This part 2 of IEC 60825 provides requirements and specific guidance for the safe operation and maintenance of optical fibre communication systems (OFCS). In these systems optical power may be accessible outside the confinements of transmitting equipment or at great distance from the optical source. This standard requires the assessment of hazard levels at accessible locations as a replacement for classification according to IEC 60825-1. It applies to the complete installed end-to-end OFCS, including its components and subassemblies that generate or amplify optical radiation. Individual components and subassemblies that are sold only to OEM vendors for incorporation into a complete installed end-to-end OFCS need not be assessed to this standard, since the final OFCS should itself be assessed according to this standard. The objective of this Part 2 of IEC 60825 is: to protect people from optical radiation resulting from OFCS; - provide requirements for manufacturers, installation organizations, service organizations and operating organizations in order to establish procedures and supply information so that proper precautions can be adopted; - ensure adequate warnings are provided to individuals regarding the potential hazards associated with OFCS through the use of signs, labels and instructions.

This part of EN 60825 provides requirements and specific guidance for the manufacture and safe use of laser products and systems used for point-to-point or point-to-multipoint free space optical data transmission. This standard only addresses the open beam portion of the system. If portions of the equipment or system incorporate optical fibre that extends from the confinements of the enclosure(s), the manufacturing and safety requirements under EN 60825-1 apply to those portions only. This standard does not apply to systems designed for purposes of transmitting optical power for applications such as material processing or medical treatment. This standard also does not apply to the use of systems in explosive atmospheres. The objective of this part of EN 60825 is to: - provide information to protect people from potentially hazardous optical radiation produced by free space optical communication systems (FSOCS) by specifying engineering controls and requirements, administrative controls and work practices according to the degree of the hazard; - specify requirements for manufacturing, installation, service and operating organisations in order to establish procedures and provide written information so that proper precautions can be adopted.

This standard lays down definitions and minimum requirements, as well as suitable test procedures, for the characteristics and manufacturing standards for detectors, instruments and equipment for the measurement of power and energy of laser radiation.

IEC 60825-1 is applicable to safety of laser products emitting laser radiation in the wavelength range 180 nm to 1 mm. A laser product may consist of a single laser with or without a separate power supply or may incorporate one or more lasers in a complex optical, electrical, or mechanical system. Typically, laser products are used for demonstration of physical and optical phenomena, materials processing, data reading and storage, transmission and display of information, etc. Such systems have found use in industry, business, entertainment, research, education, medicine and consumer products. Laser products that are sold to other manufacturers for use as components of any system for subsequent sale are not subject to IEC 60825-1, since the final product will itself be subject to this standard. However, if the laser system within the laser product is operable when removed from the equipment, the requirements of this Part 1 apply to the removable unit. Any laser product is exempt from all further requirements of this Part 1 if classification by the manufacturer of that product according to Clauses 3, 8 and 9 shows that the emission level does not exceed the AEL (accessible emission limit) of Class 1 under all conditions of operation, maintenance, service and failure. In addition to the hazards resulting from laser radiation, laser equipment may also give rise to other hazards such as fire and electric shock. This Part 1 describes the minimum requirements. Compliance with this Part 1 may not be sufficient to achieve the required level of product safety. Laser products must conform to the applicable performance and testing requirements of the applicable product safety standards. Where a laser system forms a part of equipment which is subject to another IEC product safety standard (e.g. for medical equipment (IEC 60601-2-22), IT equipment (IEC 60950), audio and video equipment (IEC 60065), equipment for use in hazardous atmospheres (IEC 60079), or electric toys (IEC 62115)), this Part 1 will apply in accordance with the provisions of IEC Guide 1042) for hazards resulting from laser radiation. If no product safety standard is applicable, then IEC 61010-1 applies. In previous editions, LEDs were included in the scope of IEC 60825-1, and they may be still included in other parts of the IEC 60825 series. However, with the development of lamp safety standards, optical radiation safety of LEDs in general can be more appropriately addressed by lamp safety standards. The removal of LEDs from the scope of this Part 1 does not preclude other standards from including LEDs whenever they refer to lasers. CIE S009 may be applied to determine the risk group class of an LED or product incorporating one or more LEDs. The MPE (maximum permissible exposure) values of this Part 1 were developed for laser radiation and do not apply to collateral radiation. However, if a concern exists that accessible collateral radiation might be hazardous, the laser MPE values may be applied to conservatively evaluate this potential hazard. The MPE values are not applicable to intentional human exposure to laser radiation for the purpose of medical or cosmetic/aesthetic treatment. The objectives of this part of IEC 60825 are the following: to introduce a system of classification of lasers and laser products according to their degree of optical radiation hazard in order to aid hazard evaluation and to aid the determination of user control measures; to establish requirements for the manufacturer to supply information so that proper precautions can be adopted; to ensure, through labels and instructions, adequate warning to individuals of hazards associated with accessible radiation from laser products; to reduce the possibility of injury by minimizing unnecessary accessible radiation and to give improved control of the laser radiation hazards through protective features.

EN following parallel vote * Superseded by EN 60825-4:2006

Superseded by EN 60825-4:2006

EN following parallel vote * Superseded by EN 60825-4:2006

Supersedes A11:1997

EN following parallel vote * Corrigendum to EN issued April 2004

EN following parallel vote * EN 60825/A2 published as EN 60825-1 * Corrigendum to EN issued February 1995

EN following parallel vote * A2 published as new edition * Superseded by EN 60825-2:2004

Corrigendum to EN/A11 issued July 1997 * Superseded by A1:2002